Contextual Intervention Adapted for Autism Spectrum Disorder: An RCT of a Parenting Program with Parents of Children Diagnosed with Autism Spectrum Disorder (ASD).

Objectives We investigated the effects of a manualized Contextual Intervention adapted for Autism Spectrum Disorders (CI-ASD), and essential elements of the intervention in promoting children’s participation and mothers’ parenting self-efficacy. Materials & Methods In this randomized controlled trial, conducted in Tehran, Iran in 2017, participants (36 parents of children with ASD) were randomly assigned to wait-list control or intervention groups. The intervention comprised contextually reﬂective occupational therapy combines 3 elements: sensory processing patterns, coaching, and social support. We provided the program to promote child’s participation and parent’s efficiency. During phase 1, the participants in the intervention group received CI-ASD as long as Treatment As Usual (TAU) and during phase 2 they received TAU only. We completed the outcome measures at three-time points (pre-intervention, post-intervention, and follow-up). We conducted semi-structured interviews post-intervention to explore acceptability of intervention and participants’ experiences of CI-ASD. Results CI-ASD can produce meaningful effects in eliminating sensory issues, promoting child participation and parenting efficiency in ASD families, compared to TAU. Parents reported high levels of acceptance and also confirmed the family’s achievements. Conclusion These gains suggest CI-ASD as an effective intervention for children who have ASD and their families, but further studies are needed to declare and generalize the findings over time. Estimated effect sizes were in the large and medium ranges and favored the intervention group.


Introduction
Enabling participation in everyday occupations for children with disabilities has become an important outcome for rehabilitation services (1).
Participation in life activities is a critical factor in children's development and facilitates learning (2). Participation is defined as the nature and extent of a person's involvement in life situations, denoting the interplay of the person, environment, and activity (3). As occupational therapists, we have unique skills to act within this interaction and understand the impact of the occupations and the environment on participation. We also see the possibilities for adapting occupations and environments to optimize the child's functioning in natural contexts (4).
Children with autism spectrum disorder (ASD) may demonstrate unusual responses to sensory stimuli and may demonstrate bizarre interests in sensory features of the contexts (5). This can influence their participation in daily activities (6).
A disparity between environmental demands and child's sensory processing patterns can contribute to less participation (7). Occupational therapists may embed sensory inputs within a child's daily routines to modulate arousal level or adapt home or school environments to promote participation (8).
Occupational performance coaching (OPC), or simply "coaching" is an intervention has recently begun to receive attention in the early intervention literature and is practiced in family-centered programs which supports parent-identified goals and problem solving. Coaching enables parents to realize and carry out therapeutic strategies within life routines (9,10). The coach does not "tell" parents what to do, instead guides them in identifying therapeutic strategies according to families' needs (11,12). Coaching has a conversational format that guides parents to identify their functional goals and determine adjustments in activities and natural environments that promote goal achievement within routines and authentic contexts. The coach may also use shaping and processing strategies to improve parent's recognition and problem-solving (13).
Although the literature inform therapists on how to administer effective coaching services (13,14), limited clues exist about using sensory processing knowledge combined with a coaching approach.
We hypothesized that implementing a contextual

Research Design
In the current research we used a randomized controlled trial with a mixed within-betweensubjects design and a wait-list control group. We completed randomization by writing children's names at random and allocating to the intervention and wait-list control groups, using a randomization block. No parties were blinded to group allocation.
Before starting the intervention, we completed the pre-intervention assessments with both the intervention and the wait-list control groups. The intervention group then received the CI-ASD and at the end of the intervention course, both groups completed the same post-intervention measures.
We also conducted semi-structured interviews to investigate parents' experience (satisfaction) of CI-ASD. Four weeks later, we conducted another round of assessments with both groups (follow up).
The wait-list control group received CI-ASD after follow-up and treatments as usual (TAU) continued for both groups, all the study long. We recorded other treatment services received by participants but did not control for them. The flowchart of the study is illustrated in Figure 2.

Measures
The Demographic Questionnaire, Short Sensory Profile II (SSP2), and Gilliam Autism Rating Scale II (GARS2) were only completed in the preintervention questionnaire pack. Parents completed all other questionnaire packs before and after the intervention, and at 4 wk follow-up.

Demographic Questionnaire
The Demographic Questionnaire contains the family background information, the child's data, received services, and contact details.

Sensory Profile II
We used the Short Sensory Profile II (SSP2), a 38-item parent questionnaire, to identify children who have sensory differences. According to its short administration time (5-10 min) and value in screening for sensory processing patterns, the SSP Iran J Child Neurol. Autumn 2019 Vol. 13 No. 4 is recommended for research protocols (15,16).
The questionnaire evaluates behaviors associated with sensory processing in children aged 3-10 yr (17). Based on a 5 point Likert scale ranging from 'always' [1] to 'never' [5], parents rate the

Goal Attainment Scaling
We used Goal Attainment Scaling [GAS; (29)] to measure improvement in functional goals in activities and routines related sensory responses.
The inter-rater reliability of the scale was declared 0.67 in various populations (30). In our study, parent and intervention therapist found prevailing problems related to sensory issues and made incremental levels into goal achievement. Each goal was rated on a 5-point scale (-2, -1, 0, +1, +2) and the current behavior was set at the level of (-2) and ultimately parents checked the level of each goal progress. If the parent obtains the expected level of identified-goal, it was graded at 0. If they obtain less than expected level it was graded at -1 and -2; if they obtain more than the expected level it was scored at +1 and +2. Evidence have suggested the GAS for measuring parents' statements of behavioral variations (12,31).

Parenting Sense of Efficacy Measure
The Parenting Sense of Efficacy Measure (PSEM) is a 10-item questionnaire (responses range from 1=strongly disagree to 7= strongly agree) that for sharing information, identifying options, and progressing toward identified goals (33).

Statistical Analysis
A series of t-test was performed for comparing means of responses in two groups. Mauchly test was performed to sphericity assumption in repeated measures ANOVA. Due to the assumption was not established (P-value<0.05), the test with adjusted degree of freedom was used (Greenhouse-Geisser).
We applied a series of repeated measures ANOVAs to explore intervention effects and maintenance.

Participants Characteristics
The power analysis indicated that for a large effect There were no meaningful differences at preintervention assessments between two groups in the most participant's characteristics, using Chi-Square, t-test and Fisher exact test as appropriate (Table 1).
We did not find any notable differences within the intervention and the wait list groups independent variables at baseline, using Independent t-test ( Table 2). The preliminary analyses corroborate the assumption of between-group comparability at the start.  (Table 5).
A series of MANOVA coefficients estimated for comparing two groups, in each measuring steps ( Table 6).
The MANOVA coefficients contrast between two groups for COPM performance indicated

Research Design
In the current research we used a randomized controlled trial with a mixed within-betweensubjects design and a wait-list control group. We completed randomization by writing children's      shifting into practice.

Limitations
We did not have blinded assessment in the present study and we had a short length of time to followup. After the study, additional researches need to be trained so that others can learn and carry out CI-ASD with desired results and fidelity. Future studies could include observational assessments of participation and self-efficacy to expand the data.
In conclusion, the gains of the present study reveal that the CI-ASD program is efficacious in eliminating children's sensory behavior issues and promoting participation and performance reported by parents and the findings provide support for the efficacy of the program in parent outcomes in the ASD families. This program has assurance for the larger community and needs additional researches.

Acknowledgement
The present research was funded by the University Even though these two published types of research declared that their intervention was effective in promoting participation and performance of children, we did not have a control group.
The current study explored the intervention effectiveness in an RCT that included a control group and consistent with Contextual Intervention, we used sensory processing model integrated with coaching approach. All of the primary outcome measures, were statistically significant and three of them evolved potentially high effect size estimates.
It is required to run further researches to evolve evidence for CI-ASD and establish an apparent guideline of the intervention so we can repeat it and gain the same results with other practitioners.